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Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access ProgramGeneticsGeneticPhase 3

What this study is

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

What's being tested

  • Previously treated CAR-T patients

    Intervention · GENETIC

    Lentiviral-based CAR-T cell therapy

Study details

Official title
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Sponsor
Novartis Pharmaceuticals
Conditions
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Enrolling
1,105 people
Starts
2015-11-02
Est. completion
2039-04-18
Design
Open-label, single group, Phase 3
Record
View on ClinicalTrials.gov ↗